Postmarket Transformation--Immediate Priority Actions

 1. Create CDRH cross-cutting “collaborative product groups” to provide the Center with a Total Product Life Cycle (TPLC) look at regulated products on a routine basis

CDRH transformed into a Matrix organization in January 2008. Thirteen cross-cutting Networks were created to enhance the Center’s ability to communicate and share information about products and scientific issues as they arise. There are nine product Networks :

1. Cardiac Electrophysiology and Monitoring,
2. Cardiothoracic and Peripheral Vascular,
3. Infection Control, Dental, General Hospital Infusion Pumps,
4. Plastic and Reconstructive Surgery and Breast Implants,
5. General Surgery,
6. Physical Medicine, Ob/Gyn,
7. Ophthalmics and ENT,
8. Orthopedics,
9. Gastroenterology, Urology and Renal, and
10. Neurology, Anesthesia and Respiratory.

In addition, there are four cross-cutting issues or diagonal Networks that deal with products or device issues that span across different Networks and Offices. These four networks are:

10. Science,
11. Regulatory and Special Interest,
12. Radiological Health, and
13. Diagnostics.

CDRH is developing processes to collect, analyze and act on these issues as well as partner with outside organizations to develop databases to help understand the information gathered from these various sources. We are also working to integrate internal databases to allow a better search capability for our data. CDRH is piloting collaboration software that will enhance our ability to share information readily with one another.

For more information, contact Jonathan Sackner-Bernstein

 2. Develop methods and metrics for tracking and assessing progress in the Center’s performance in handling postmarket issues

CDRH is developing a set of valid metrics and methods for tracking and assessing the progress of our performance regarding the Matrix and the Center’s postmarket processes. The Center has determined what the valid qualitative metrics are and is working to determine how to make them measurable. External stake holders will be an integral part of the final product.

CDRH will continue internal analysis of the best qualitative measures available while looking at what is currently being used externally to measure postmarket safety. This work is in the early stages of development.

For more information, contact Jonathan Sackner-Bernstein.

 3. Pursue the development of unique identifiers (UDI) for medical devices, in collaboration with industry and health care providers, in order to easily identify specific devices when postmarket questions are raised

On September 27, 2007, the Food and Drug Administration Amendments Act (FDAAA) of 2007 was signed into law. This act includes language related to the establishment of a Unique Device Identification (UDI) System. This new system when implemented will require:

• the label of a device to bear a unique identifier, unless an alternative location is specified by FDA or unless an exception is made for a particular device or group of devices;
• the unique identifier to be able to identify the device through distribution and use; and
• the unique identifier to include the lot or serial number if specified by FDA.

CDRH is drafting legislation to implement these requirements.

In support of the law, CDRH is:

• developing a rule that will specify a required globally harmonized unique device identification code to be placed on medical devices;
• ensuring that the unique device identification includes GMDN codes for global harmonization; and
• working with standards efforts and the medical device industry.

More information on UDI 

 4. Optimize the Center’s passive surveillance systems by making electronic reporting of adverse event data mandatory (“eMDR”)

Collecting adverse event information on medical devices is mandated by Medical Device Reporting (MDR) requirements of the Food, Drug and Cosmetics act (FD&C Act) (21 USC 360i) and comes primarily from manufacturers, user facilities, importers and voluntary reporters. Currently a majority of these reports are entered manually by data entry contractors.

More information on high and low volume reporting is available on the eMDR web site.

 5. Update the MAUDE system and expand the premarket data warehousing effort to include postmarket applications

A critical goal for CDRH is to provide our staff with the tools needed to identify, analyze, and act upon information about adverse events to continue to assure the safety and effectiveness of marketed medical devices.  CDRH has undertaken a process to replace its 10 year old current adverse event database system with a new system.  The new system, FDA Adverse Event Reporting System (FAERS), will eventually be used by all FDA centers to store, retrieve, and analyze adverse event reports using the most current technology possible.

CDRH is working closely with other Centers to design and implement an integrated database for adverse event reports.  The new system, FAERS, will replace the Adverse Event Reporting System (AERS) also used by other FDA Centers.  FAERS will provide staff the ability to access and use adverse event data about drugs, biologics, devices, and combination products. FAERS will incorporate state-of-the-art analytical tools so that the staff can analyze information more comprehensively.

For more information, contact Steve Sykes.

 6. Transform the quantity and quality of Center/ORA interactions through increased collaboration within CDRH and among CDRH, ORA and OCC

In order to transform CDRH’s interactions with the Office of Regulatory Affairs (ORA), CDRH is working to improve collaboration on a variety of fronts to reach this goal. Routine communication on compliance and enforcement activities occurs between ORA and CDRH. Discussion topics include enforcement initiatives and significant process related issues. In addition, CDRH is supportive and participates on ORA committees tasked with development of programs related to the ORA reorganization.

This year, Congress provided additional resources to address important issues confronting FDA. ORA and CDRH are collaborating to allocate these resources in an effective, risk-based manner. Important medical devices issues include import safety, surveillance inspections, follow up on recalled products, international harmonization, registration and listing, and premarket submission support.

As a way to foster collaboration, CDRH is aggressively working with ORA University to revise training programs and certification programs to enhance the quality of the courses offered.  CDRH provides expert instructors for ORA University classes and CDRH senior staff participate in class advisory groups. CDRH is also conducting intensified data mining and analysis on recalls and root causes.  These analyses and their use in premarket and postmarket issues are intended to lead to more informed reviews throughout the life cycle of the devices. 

Continuing towards our goal, CDRH plans to implement the Agency’s Import Safety Action Plan. The risk-based collaborative inspection assignment process will also be reconstituted.

For more information, contact Tim Ulatowski.

 

 7. Develop and implement a risk-communication strategy to maximize CDRH’s ability to communicate information in a clear and timely way to practitioners, patients and consumers

The Center’s goal with the Risk Communication Strategy is to maximize its ability to communicate information in a clear and timely way to practitioners, patients, and consumers. To accomplish this, the Center will 1) Develop a Risk Communication strategy and 2) improve the quality, and expand the use of, the Center’s communications tools. In turn, CDRH will be a trusted, publicly identifiable source for safety information about medical devices and radiation-emitting products.

To reach this goal, the Center has:

• Conducted focus group studies of how patients and family members learn about risks of medical devices
• Conducted focus group studies of how the term ‘Recall’ is perceived by health care professionals and consumers
• Conducted focus group studies of how patients and family members learn about risks of medical devices
• Formed a Center-wide Team to address risk communication project goals
• Published a guidance document on best practices for writing Dear Doctor Letters on recalls of Implantable Cardioverter Defibrillators (ICDs)

Continuing towards our goal, the Center is conducting an internal assessment of all policies and procedures that support a consistent and coordinated risk communication program.

For more information, contact Lynne Rice.

8. Design a pilot project to test whether quantitative decision-making methods can be useful in regulating medical devices across the Total Product Life Cycle (TPLC)

CDRH is exploring the use of quantitative decision-making methodology (mathematical calculations of risk, benefits, and predictive relationships with adverse events) as a tool in quantifying risks associated with the use of medical devices. 

After a successful pilot of the methods, we will:

• Construct a template for using decision-making methods at all stages of TPLC – pre-IDE/IDE (if applicable), review of premarket applications, postmarket data collection and analysis, compliance/enforcement,
• Use available information about the products in the decision-analysis framework and evaluate what this tells us about the product,
• Develop and validate analytic tools both for identification of issues and determination of the optimal time for decision making in the post market phase, and
• Evaluate the performance of, and refine our decision-analysis methods.

For more information, contact Jonathan Sackner-Bernstein.

 9. Increase active surveillance by enhancing MedSun programs that reach out to participants and get answers to pressing public health questions

CDRH launched the Medical Product Surveillance Network (MedSun) in 2002.  The primary goal for MedSun is to collaborate with the clinical community to identify, understand, and share information about problems with the use of medical devices.

Over 350 health care facilities, primarily hospitals, participate in the MedSun network.  MedSun is expanding its potential by meeting the following goals: 

• Expand the use of MedSun hospitals to obtain real-time information on postmarket problems
• Feed safety information obtained from MedSun participants back to all stakeholders in order to make information equally available to all health care facilities and the public
• Target high-risk user facility areas by providing some clinical staff in MedSun participating facilities (in addition to the current risk managers and biomedical engineers) the ability to report device-related adverse events directly to CDRH

For more information on MedSun can be found on the MedSun web site.

Updated March 4, 2009